The FDA Does No Safety Testing—Says Drug Companies’ Own Studies Are Good Enough

American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). The center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

However, most consumers don’t realize that the FDA does not independently review drugs, but rather relies, in large part, on safety and efficacy information supplied by drug manufacturers themselves.

That’s right—the supposedly independent, objective research given to the FDA is conducted by pharmaceutical industry insiders and academics on the payroll of the drug companies. And this provides many opportunities for deceit and manipulation. In addition, as we discuss in our article on drug trial safety concerns, drug companies are not obligated to provide all of their data—or even any negative findings. They are allowed to cherry-pick the studies they like, and bury the rest.

“FDA is shifting…the safety risk to consumers”

The US Government Accountability Office (GAO), an independent organization that reviews government agencies, says the FDA is failing in its responsibility to monitor the safety of drugs approved through its expedited programs. Sen. Rosa DeLauro (D-CT), who requested the investigation, said that the results “confirm my greatest fear”:

FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective….If FDA is shifting more of the safety risk to consumers by allowing fewer and shorter clinical trials on expedited drugs, adequate tracking of drug safety issues and review of post market studies are absolutely vital.

The FDA can require post-market studies and clinical trials to be conducted on approved drugs, but the GAO report found the FDA did not adequately track the post-market trials for drugs approved under the accelerated program—in fact, FDA staff found such duties to be “time-consuming” and “burdensome,” according to the report.

As we’ve seen elsewhere on this site, putting the needs of drug manufacturers before consumer safety is hardly aberrant behavior for the FDA.

The European regulatory agencies rejected Xeljanz twice on safety grounds: it “had major concerns about the overall safety profile of Xeljanz” and was “of the opinion that the benefits of Xeljanz did not outweigh its risks.”

Or consider Ketek, an antibiotic developed about a decade ago. FDA inspectors uncovered fraud in the clinical trials of the drug, yet hid the problems from the committee that voted to approve the drug. It wasn’t until after reports started coming in that the drug was causing liver damage resulting in four deaths that the FDA pulled Ketek from the market for all indications except pneumonia.

In 2011, the FDA found that about 100 drugs—including chemotherapy treatments and generic ibuprofen—had been approved based on fraudulent tests performed by Cetero Research, a firm used by major drug companies around the world. In response to this public health crisis, the FDA kept the matter quiet, refusing to pull any of the drugs from the market—some of which remain on store shelves to this day despite no additional scientific evidence proving the safety and efficacy of the tainted drugs.

There are too many examples to count of what happens when the fox is left to guard the henhouse. If Big Pharma is left to conduct its own safety tests on its drugs, we can only expect more dangerous, life-threatening drugs to be rubber-stamped by the FDA and more patients to suffer as a result.

As we discuss in this article, the FDA often approves drug it knows are dangerous, and are only withdrawn after a drug causes an overwhelming number of serious adverse effects, as it did with Vioxx.

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